Any Adverse Event
Item
Was any adverse event reported or observed?
boolean
Adverse Event
Item
Adverse Event
text
Onset Date
Item
Onset Date
date
End Date
Item
End Date
date
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae (4)
Item
Course of Event
text
Code List
Course of Event
CL Item
Single Episode (1)
Serious AE
Item
Serious AE?
boolean
Serious AE Number
Item
Serious AE Number
integer
Requires or prolongs hospitalization
Item
Requires or prolongs hospitalization
boolean
Congenital anomaly
Item
Congenital anomaly
boolean
Life-threatening
Item
Life-threatening
boolean
Disability
Item
Persistent or significant disability/incapacity
boolean
Medical Importance
Item
Other medical importance
boolean
Item
Action Taken for Study Drug
text
Code List
Action Taken for Study Drug
CL Item
Dose Not Changed (1)
CL Item
Drug Interrupted (2)
CL Item
Drug Withdrawn (3)
CL Item
Not Applicable (4)
Treatment
Item
Was there any treatment required?
boolean
Medication Therapy
Item
Medication Therapy
boolean
Non-Medication Therapy
Item
Non-Medication Therapy
boolean
Item
Relationship to Study Drug
text
Code List
Relationship to Study Drug